The testimony of the drug Liorezal
Severe chronic spasticity with the defeat of the spinal cord (e.g. due to injury, and multiple sclerosis) or brain with the ineffectiveness or intolerance to therapy muscle relaxants oral.
hypersensitivity to baclofen or to any other component of the drug;
children age ≤4 years (efficacy and safety of the drug in children under 4 years of age have not been established).
This drug should not be used in/in, in/m, p/or epidural!
children aged ≤18 years for installation of the implantable infusion system in children the necessary condition is the availability of a sufficient body mass (see "instructions for use of the implantable infusion system"). Clinical data on the use of the drug in children younger than 6 years is limited;
patients aged ≥65 years in clinical trials using the drug Liorezal Intrathecal in patients aged ≥65 years, the tolerability was similar to that in young patients. In patients aged ≥65 years receiving baclofen inside, in some cases there was an increase in the frequency of adverse events (AES), especially during titration. In applying the drug in this category of patients, we cannot exclude the possibility of increasing the risk of developing AES. However, individual selection of doses of the drug increase in frequency of AES in patients of advanced age is unlikely;
disturbed circulation of cerebrospinal fluid (CSF) — anti-spastic activity of the drug may differ from that of patients with normal CSF circulation due to uneven distribution of baclofen into the subarachnoid space;
mental disorders, including schizophrenia, confusion and Parkinson's disease — since there are cases of exacerbation of these diseases (conditions) in the application of baclofen inside (requires careful monitoring of patients);
epilepsy — because there are known cases of seizures with drug overdose, as well as during maintenance therapy and after its termination;
autonomic dysfunction (dysreflexia) in history — the emergence of paroxysmal autonomic dysfunction can be triggered by painful stimulus or a sudden cessation of drug administration;
cerebrovascular or respiratory insufficiency — since baclofen may worsen these conditions;
ulcerative lesions of the gastrointestinal tract (including history), hypertonicity of the sphincter, impaired renal function — worsening of comorbidities not related to CNS disorders, on the background of drug therapy is unlikely, since the introduction of intrathecal systemic effects of baclofen significantly less pronounced compared to taking it in. However, care should be taken when administering the drug;
Application of pregnancy and breastfeeding
In experimental studies when taking baclofen orally in doses approximately 13 times the maximum oral dose (based on mg/kg), recommended in clinical practice, a marked increase in the frequency of umbilical (ventral) hernias. In pregnant women no adequate and well-controlled studies have not been conducted. Baclofen crosses the placenta. The drug Liorezal Intrathecal should not be used during pregnancy, except in those cases where the expected positive effect of therapy for the mother outweighs the potential risk to the fetus.
Women taking baclofen orally at therapeutic doses, the drug enters the breast milk, but in quantities insufficient to be able to expect the development of adverse reactions in children. It is unknown whether baclofen excreted in breast milk in intrathecal administration. During the period of use of the drug, breastfeeding should be discontinued.
Method of application and doses
Intrathecal, for the introduction of a single test doses (via a catheter located in the spinal canal, or by lumbar puncture) and long term use with implantable pump for continuous administration of the drug in the subarachnoid space.